Double-Balloon Catheter-Mediated Transarterial Chemotherapy Delivery in a Swine Model: A Mechanism Recruiting the Vasa Vasorum for Localized Therapies.

PURPOSE: Treatment of hypovascular tumors, such as pancreatic adenocarcinoma, is challenging owing to inefficient drug delivery. This report examines the potential mechanism of localized drug delivery via transarterial microperfusion (TAMP) using a proprietary adjustable double-balloon occlusion catheter in a porcine model. MATERIALS AND METHODS: Adult Yorkshire swine (N = 21) were used in the Institutional Animal Care & Use Committee-approved protocols. The RC-120 catheter (RenovoRx, Los Altos, California) was positioned into visceral, femoral, and pulmonary arteries with infusion of methylene blue dye, gemcitabine, or gold nanoparticles. Transmural delivery was compared under double-balloon occlusion with and without side-branch exclusion, single-balloon occlusion, and intravenous delivery. Intra-arterial pressure and vascular histologic changes were assessed. RESULTS: Infusion with double-balloon occlusion and side-branch exclusion provided increased intra-arterial pressure in the isolated segment and enhanced perivascular infusate penetration with minimal vascular injury. Infusates were predominantly found in the vasa vasorum by electron microscopy. CONCLUSIONS: TAMP enhanced transmural passage mediated by localized increase in arterial pressure via vasa vasorum.

Effect of Previous Transarterial Chemoembolization on Survival and Toxicity after Yttrium-90 Transarterial Radioembolization of Hepatocellular Carcinoma in the Radiation-Emitting SIR-Spheres in Nonresectable Liver Tumor Registry.

PURPOSE: To determine overall survival (OS), best response, and toxicities in patients with hepatocellular carcinoma (HCC) previously treated with chemoembolization (TACE+) or yttrium-90 resin transarterial radioembolization (TARE) compared with those of TACE-naïve (T-N) participants. MATERIALS AND METHODS: In this prospective, observational study, 262 adult participants with HCC were divided into TACE+ (n = 93, 35%) or T-N (n = 169, 65%) groups, included from 36 centers in the United States. Overall survival (OS) was assessed using Kaplan-Meier analysis from the date of TARE. Best response at 6 months was evaluated using modified Response Evaluation Criteria in Solid Tumors. Six-month toxicities were reported using Common Terminology Criteria for Adverse Events, version 5. RESULTS: Median OS for patients in the TACE+ and T-N groups was 22.3 months (95% CI: 17.2 to not reachable) and 21.5 months (95% confidence interval [CI]: 14.9-29.9), respectively (P = .6). Imaging at 6 months ± 2 weeks was available in 156 of 262 (60%) participants. Partial or complete response was seen in 27 of 55 patients (49%) in the TACE+ group and 65 of 101 patients (64%) in the T-N group (P = .2). Six-month toxicities were available in 69 of 93 patients (74%) in the TACE+ group and 135 of 167 patients (81%) in the T-N group. Attributable Grade 3 or greater liver function toxicities were similar between the study groups (all P > .05). CONCLUSIONS: OS and imaging response at 6 months in the TACE+ group was similar to that in the T-N group with similar toxicities. Radioembolization is an acceptable treatment option for patients with HCC previously treated with TACE.

Survival and Toxicities after Yttrium-90 Transarterial Radioembolization of Cholangiocarcinoma in the RESiN Registry.

PURPOSE: To report outcomes in patients with intrahepatic cholangiocarcinoma treated with yttrium-90 resin microspheres (transarterial radioembolization [TARE]) from a multicenter, prospective observational registry. MATERIALS AND METHODS: Ninety-five patients (median age, 67 years [interquartile range {IQR}, 59-74]; 50 men) were treated in 27 centers between July 2015 and August 2020. Baseline demographic characteristics included imaging findings, performance status, and previous systemic or locoregional treatments. Dosimetry method was tracked. Overall survival (OS) and progression-free survival were calculated using the Kaplan-Meier method. The best imaging response was calculated using the Response Evaluation Criteria in Solid Tumors v1.1. Grade ≥3 toxicities were assessed using Common Terminology Criteria for Adverse Events v5. Cox regression analysis was performed. RESULTS: Fifty-two of 86 (60%) patients had multifocal tumors, and 24/89 (27%) had extrahepatic tumors. The median index tumor diameter was 7.0 cm (IQR, 4.9-10 cm). The activity calculation method was reported in 59/95 (62%) patients, with body surface area being the most frequently used method (45/59, 76%). Median OS for the cohort was 14 months (95% confidence interval, 12-22). OS at 3, 6, 12, and 24 months was 94%, 80%, 63%, and 34%, respectively. Median OS was longer in patients without cirrhosis (19.1 vs 12.2 months, P = .05). Cirrhosis, previous chemotherapy (OS, 19.1 vs 10.6 months for treatment-naïve; P = .07), and imaging response at 6 months (OS, 16.4 vs 9.5 months for no response; P = .06) underwent regression analysis. Imaging response predicted OS at regression (hazard ratio, 0.39; P = .008). Grade 3-4 bilirubin toxicities were noted in 5 of 72 (7%) patients. Grade 3 albumin toxicity was noted in 1 of 72 (1.4%) patients. CONCLUSIONS: Objective response at 6 months predicted longer OS after TARE for intrahepatic cholangiocarcinoma. The incidence of liver function toxicity was <10%.

REBOA: Expanding Applications From Traumatic Hemorrhage to Obstetrics and Cardiopulmonary Resuscitation, From the AJR Special Series on Emergency Radiology.

Resuscitative endovascular balloon occlusion of the aorta (REBOA) has emerged over the past decade as a technique to control life-threatening hemorrhage and treat hemorrhagic shock, being increasingly used to treat noncompressible traumatic torso hemorrhage. Reports during this time also support the use of a REBOA device for an expanding range of indications including nontraumatic abdominal hemorrhage, postpartum hemorrhage, placenta accreta spectrum (PAS) disorder, and cardiopulmonary resuscitation (CPR). The strongest available evidence supports REBOA as a lifesaving adjunct to definitive surgical management in trauma and as a method to help avoid hysterectomy in select patients with postpartum hemorrhage or PAS disorder. In comparison with initial descriptions of complete REBOA inflation, techniques for partial REBOA inflation have been introduced to achieve hemodynamic stability while minimizing adverse events relating to reperfusion injuries. Fluoroscopy-free REBOA has been described in various settings, including trauma, obstetrics, and out-of-hospital cardiac arrest. As the use of REBOA expands outside the trauma setting and into nontraumatic abdominal hemorrhage, obstetrics, and CPR, it is imperative for radiologists to become familiar with this technology, its proper placement, and its potential adverse sequelae.

Survival and Toxicities after 90Y Transarterial Radioembolization of Metastatic Colorectal Cancer in the RESIN Registry.

Background Patients with unresectable, chemorefractory hepatic metastases from colorectal cancer have considerable mortality. The role of transarterial radioembolization (TARE) with yttrium 90 (90Y) microspheres is not defined because most reports are from a single center with limited patient numbers. Purpose To report outcomes in participants with colorectal cancer metastases treated with resin 90Y microspheres from a prospective multicenter observational registry. Materials and Methods This study treated enrolled adult participants with TARE using resin microspheres for liver-dominant metastatic colorectal cancer at 42 centers, with enrollment from July 2015 through August 2020. TARE was used as the first-, second-, or third-line therapy or beyond. Overall survival (OS), progression-free survival (PFS), and toxicity outcomes were assessed by line of therapy by using Kaplan-Meier analysis for OS and PFS and Common Terminology Criteria for Adverse Events, version 5, for toxicities. Results A total of 498 participants (median age, 60 years [IQR, 52-69 years]; 298 men [60%]) were treated. TARE was used in first-line therapy in 74 of 442 participants (17%), second-line therapy in 180 participants (41%), and third-line therapy or beyond in 188 participants (43%). The median OS of the entire cohort was 15.0 months (95% CI: 13.3, 16.9). The median OS by line of therapy was 13.9 months for first-line therapy, 17.4 months for second-line therapy, and 12.5 months for third-line therapy (χ2 = 9.7; P = .002). Whole-group PFS was 7.4 months (95% CI: 6.4, 9.5). The median PFS by line of therapy was 7.9 months for first-line therapy, 10.0 months for second-line therapy, and 5.9 months for third-line therapy (χ2 = 8.3; P = .004). TARE-attributable grade 3 or 4 hepatic toxicities were 8.4% for bilirubin (29 of 347 participants) and 3.7% for albumin (13 of 347). Grade 3 and higher toxicities were greater with third-line therapy for bilirubin (P = .01) and albumin (P = .008). Conclusion Median overall survival (OS) after transarterial radioembolization (TARE) with yttrium 90 microspheres for liver-dominant metastatic colorectal cancer was 15.0 months. The longest OS was achieved when TARE was part of second-line therapy. Grade 3 or greater hepatic function toxicity rates were less than 10%. Clinical trial registration no. NCT02685631 Published under a CC BY 4.0 license. Online supplemental material is available for this article. See also the editorial by Liddell in this issue.

Long-term outcomes following 90Y Radioembolization of neuroendocrine liver metastases: evaluation of the radiation-emitting SIR-spheres in non-resectable liver tumor (RESiN) registry.

BACKGROUND: The goal of this study was to evaluate efficacy and safety of 90Y radioembolization for neuroendocrine liver metastases (NELM) in a multicenter registry. METHODS: One hundred-seventy patients with NELM were enrolled in the registry (NCT02685631). Prior treatments included hepatic resection (n = 23, 14%), arterial therapy (n = 62, 36%), octreotide (n = 119, 83%), cytotoxic chemotherapy (n = 58, 41%), biologic therapy (n = 49, 33%) and immunotherapy (n = 10, 6%). Seventy-seven (45%) patients had extrahepatic disease. Seventy-eight (48%), 61 (37%), and 25 (15%) patients were Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or ≥ 2. Tumor grade was known in 81 (48%) patients: 57 (70%) were well-, 12 (15%) moderate-, and 12 (15%) poorly-differentiated. Kaplan-Meier analysis and log rank tests were performed to compare overall and progression-free survival (OS/PFS) by tumor location and grade. Toxicities were reported using Common Terminology Criteria for Adverse Events v.5. Cox Proportional Hazards were calculated for pancreatic primary, performance status, extrahepatic disease at treatment, unilobar treatment, baseline ascites, and > 25% tumor burden. RESULTS: One, 2, and 3-year OS rates were 75, 62 and 46%, respectively. Median OS was 33 months [(95% CI: 25-not reached (NR)]. The longest median OS was in patients with pancreatic (42 months, 95% CI: 33-NR) and hindgut 41 months, 95% CI: 12-NR) primaries. The shortest OS was in foregut primaries (26 months; 95% CI: 23-NR; X2 = 7, p = 0.1). Median OS of well-differentiated tumors was 36 months (95% CI: 10-NR), compared to 44 (95% CI: 7-NR) and 25 (95% CI: 3-NR) months for moderate and poorly differentiated tumors. Median progression-free survival (PFS) was 25 months with 1, 2, and 3-year PFS rates of 70, 54, and 35%, respectively. Thirteen patients (7.6%) developed grade 3 hepatic toxicity, most commonly new ascites (n = 8, 5%) at a median of 5.5 months. Performance status of ≥2 (HR 2.7, p = 0.01) and baseline ascites (HR 2.8, P = 0.049) predicted shorter OS. DISCUSSION: In a population with a high incidence of extrahepatic disease, 90Y was effective and safe in treatment of NELM, with median OS of 41 months for well differentiated tumors. Grade 3 or greater hepatic toxicity was developed in 7.6% of patients. TRIAL REGISTRATION: NCT02685631 .

Overall survival and toxicity of Y90 radioembolization for hepatocellular carcinoma patients in Barcelona Clinic Liver Cancer stage C (BCLC-C).

INTRODUCTION: National Comprehensive Cancer Network HCC guidelines recommend Y90 to treat BCLC-C patients only in select cases given the development of systemic regimens. We sought to identify ideal candidates for Y90 by assessing survival and toxicities in this patient group. MATERIALS AND METHODS: The Radiation-Emitting Selective Internal radiation spheres in Non-resectable tumor registry is a prospective observational study (NCT: 02,685,631). Patients with advanced HCC were stratified into 3 groups based on tumor location, Eastern Cooperative Oncology Group (ECOG) performance status, and liver function. Group 1: liver isolated HCC, ECOG 0 and Child Pugh (CP) A (n = 12, 16%), Group 2: liver isolated HCC, ECOG ≥ 1 or CP B/C (n = 37, 49%), and Group 3: extrahepatic HCC with any ECOG or CP score (n = 26, 35%). Patients in any group could have macrovascular invasion. Overall survival (OS) and progression-free survival (PFS) with 95% confidence intervals (95% CI) were calculated. Grade 3 + toxicities were tracked using Common Terminology Criteria for Adverse Events v5. Cox proportional hazard model was performed to determine factors affecting OS. RESULTS: Seventy-five BCLC-C patients treated between 2015 and 2019 were reviewed. The groups were similar in age, sex, race, and ethnicity (all p > 0.05). Bilobar disease was least common in Group 1 (p < 0.001). Median OS of the entire cohort was 13.6 (95% CI 7.5-16.1) months. Median OS of Groups 1-3 were 21.8, 13.1 and 11.5 months respectively (p = 0.6). Median PFS for the cohort was 6.3 (4.8-14.7) months. Median PFS for group 1 was not reached. Mean PFS for Group 1 was 17.3 ± 4.8 months. Median PFS for Groups 2 and 3 was 6.8 and 5.9 months (X2 = 1.5, p = 0.5). Twenty-four Grade 3 or greater toxicities developed, most commonly hyperbilirubinemia (8/75, 11%) and thrombocytopenia (2/75, 3%). The incidence of toxicities between groups was similar (all p > 0.05). Cox Proportional Hazard analysis predicted shorter OS with CP class B/C (X2 = 6.7, p = 0.01), while macrovascular invasion (X2 = 0.5, p = 0.5) and ECOG score of ≥ 1 (X2 = 2.1, p = 0.3) was not associated with OS. CONCLUSIONS: OS of CPA patients with advanced HCC and performance status of 0 was 21.8 months following Y90. CP A cirrhosis is the best predictor of prolonged OS in advanced (BCLC-C) HCC.

Improving IR Ergonomics Using a Flexible C-Arm System.

PURPOSE: To evaluate the impact of a versatile flexible ceiling-mounted C-arm on active table and gantry repositioning during interventions and its effect on operator discomfort, system usability, and patient safety compared with a traditional ceiling-mounted system. MATERIALS AND METHODS: There were 100 IR procedures studied: 50 in a traditional IR system (standard group) and 50 with a novel multiaxis ceiling-mounted system (test group). FlexArm was capable of multiple gantry rotation points allowing increased access to the patient in addition to 236 cm of lateral x-ray detector travel. For each procedure, both the table and the gantry repositioning were measured. Patient safety, patient/equipment repositioning effort, and physical discomfort were evaluated through an operator survey. RESULTS: Table repositioning was reduced from 42 to 16 instances per procedure (P < .001) in the test group compared with the standard group. The operators perceived less table and gantry repositioning effort (P < .0001) and decreased risks of equipment collisions, displacement of vascular access, and dislodgment of tubes/lines with the test group (P < .0001). Operator discomfort was reduced for all body areas in the test group over the standard group (P < .0001). CONCLUSIONS: The FlexArm system geometry enhances operator ergonomics, as there was a decrease need to move the table, leading to a perceived decrease in patient risk and decrease operator physical discomfort when compared to a traditional imaging system.

Multicenter Evaluation of Survival and Toxicities of Hepatocellular Carcinoma following Radioembolization: Analysis of the RESiN Registry.

PURPOSE: To determine overall survival (OS), progression-free survival (PFS), and toxicity in patients with hepatocellular carcinoma (HCC) in a multicenter, real-world data registry using transarterial radioembolization (TARE) with resin microspheres. MATERIALS AND METHODS: A total of 448 patients with HCC were treated at 36 centers between 2015 and 2019. Treatment history, baseline laboratory and imaging, and treatment goal were assessed. OS and PFS were stratified using Barcelona Clinic Liver Cancer (BCLC) and Child-Pugh (CP) classifications. Kaplan-Meier analyses compared OS and PFS with 95% confidence intervals. Transplants were tracked. Toxicities were assessed using Common Terminology Criteria for Adverse Events v5. Cox proportional hazard of baseline demographics assessed factors affecting survival. RESULTS: Prior chemoembolization and systemic therapy were used in 107 (26%) and 68 (16%) patients, respectively. Using the BCLC staging system, 66 patients (19%) were BCLC A and 202, 51, and 26 were BCLC B, C, and D, respectively. Median OS for patients with BCLC A disease was not achieved at 30 months. Median OS for patients with BCLC B, C, and D disease were 19.5, 13.6, and 11.5 months, respectively (P = .0006). Median PFS for patients with BCLC A, B, C, and D were 19.8, 10.0, 6.3, and 5.9 months, respectively (P = .003). Twenty patients underwent transplantation, representing 14 of 43 (33%) and 6 of 28 (21%) patients who underwent bridging and downstaging therapy, respectively. Common Grade 3 toxicities were encephalopathy (11/448, 2.5%), hyperbilirubinemia (10/448, 2.2%), and ascites (9/448, 2.0%). Factors predicting longer survival included CP A (χ2 = 4.2, P = .04) and BCLC A (χ2 = 5.2, P = .02). CONCLUSIONS: In a frequently pretreated patient cohort with disease burden in 81% beyond the Milan criteria, TARE with resin microspheres provided OS comparable to other studies in this multicenter registry.

Early clinical experience with a touchless image navigation interface for the endovascular suite.

Introduction: The inability to having comprehensive access to all pertinent imaging data related to an endovascular procedure in the sterile field is an unmet need, and its absence may have deleterious effects on decision-making, outcomes and workflow. Current image navigation solutions rely on traditional personal computing interfaces which are difficult to use in the sterile field. Innovative technological solutions are needed to address this need.Material and methods: Utilizing novel hardware and software integration, a human computer interaction (HCI) based platform has been developed through an iterative design and development process, that allows intuitive real-time access to imaging data in the sterile field. Following validation and pre-clinical testing, the platform has been introduced to the endovascular suite for clinical use.Results: Three prospective case-based observational reviews are presented that demonstrate the utility of touchless image navigation in the sterile field in facilitating decision-making and resource utilization during endovascular procedures, while avoiding the cognitive and workflow disturbances inherent in leaving the sterile field or involving non-scrubbed third persons in the image navigation process.Conclusion: Physician engagement and 'needs-based' technological innovation is needed to improve human computer interaction in the endovascular suite, in hopes of positively affecting procedural decision-making, outcomes, and workflow.

90Y Radioembolization for Hepatic Malignancy in Patients with Previous Biliary Intervention: Multicenter Analysis of Hepatobiliary Infections.

Purpose To determine the frequency of hepatobiliary infections after transarterial radioembolization (TARE) with yttrium 90 (90Y) in patients with liver malignancy and a history of biliary intervention. Materials and Methods For this retrospective study, records of all consecutive patients with liver malignancy and history of biliary intervention treated with TARE at 14 centers between 2005 and 2015 were reviewed. Data regarding liver function, 90Y dosimetry, antibiotic prophylaxis, and bowel preparation prophylaxis were collected. Primary outcome was development of hepatobiliary infection. Results One hundred twenty-six patients (84 men, 42 women; mean age, 68.8 years) with primary (n = 39) or metastatic (n = 87) liver malignancy and history of biliary intervention underwent 180 procedures with glass (92 procedures) or resin (88 procedures) microspheres. Hepatobiliary infections (liver abscesses in nine patients, cholangitis in five patients) developed in 10 of the 126 patients (7.9%) after 11 of the 180 procedures (6.1%; nine of those procedures were performed with glass microspheres). All patients required hospitalization (median stay, 12 days; range, 2-113 days). Ten patients required percutaneous abscess drainage, three patients underwent endoscopic stent placement and stone removal, and one patient needed insertion of percutaneous biliary drains. Infections resolved in five patients, four patients died (two from infection and two from cancer progression while infection was being treated), and one patient continued to receive suppressive antibiotics. Use of glass microspheres (P = .02), previous liver resection or ablation (P = .02), and younger age (P = .003) were independently predictive of higher infection risk. Conclusion Infectious complications such as liver abscess and cholangitis are uncommon but serious complications of transarterial radioembolization with 90Y in patients with liver malignancy and a history of biliary intervention.

Colorectal Liver Metastasis: Overview of Treatment Paradigm Highlighting the Role of Ablation.

OBJECTIVE: The objective of this article is to discuss the current treatment options for colorectal cancer (CRC) liver metastases and the role of ablation. CONCLUSION: A randomized control trial of ablation combined with chemotherapy showed improved overall survival compared with chemotherapy alone. Local recurrence rates are comparable to those associated with resection when ablative margins of more than 5 mm are achieved and target lesions are smaller than 3 cm. In patients with unresectable disease, ablation for curative intent should be considered.

Effect of ß-blocker on aneurysm sac behavior after endovascular abdominal aortic repair.

OBJECTIVE: This study was conducted to determine whether ß-blocker (BB) therapy is associated with abdominal aortic aneurysm (AAA) sac regression after endovascular abdominal aortic repair (EVAR). METHODS: A total of 198 patients (mean age, 76 years) who underwent EVAR were analyzed (104 in the BB group and 94 in the non-BB group). The primary end point was the incidence of AAA sac regression at 1 and 2 years. RESULTS: Hypertension, coronary artery disease, and hyperlipidemia were more common in the BB group. The BB group was also more likely to have been prescribed an aspirin and a statin than the non-BB group. The length of proximal neck was significantly longer in the non-BB group than in the BB group. All study patients were monitored for at least 1 year after EVAR, and 2-year follow-up was available in 104 patients (52.5%). There was no statistically significant difference in the incidence of aneurysm sac regression in either group at 1 year (52.1% in the non-BB group vs 45.2% in the BB group; P = .330) and 2 years (58.5% in the non-BB group vs 64.7% in the BB group; P = .515). The difference of the change of AAA maximum diameter between two groups did not reach statistical significance at 1 year (-6.0 ± 7.0 mm in the non-BB group vs -5.5 ± 8.1 mm in the BB group; P = .644) and 2 years (-9.0 ± 10.5 mm in the non-BB group vs -9.0 ± 10.0 mm in the BB group; P = .977). BB therapy was not associated with increased odds of AAA sac regression. The effect of third-generation BBs on AAA sac regression was not significant. CONCLUSIONS: BB therapy had no effect on AAA sac regression. At the present time, there is insufficient evidence to recommend BB therapy for the purpose of AAA sac regression.

Influence of Statin Therapy on Aneurysm Sac Regression after Endovascular Aortic Repair.

PURPOSE: To determine whether statin therapy is associated with abdominal aortic aneurysm (AAA) sac regression after endovascular aneurysm repair (EVAR). MATERIALS AND METHODS: A total of 109 patients treated with EVAR were retrospectively analyzed (no-statin group, n = 45; statin group, n = 64). The primary endpoint was the incidence of AAA sac regression. To investigate independent predictors of AAA sac regression, regression analysis was performed. The mean age was 74 years (range, 55-90 y), and 87.2% of patients were men. RESULTS: The no-statin group had higher rates of AAA sac regression than the statin group at 1 year (no-statin group, 66.7%; statin group, 45.3%; P = .028). The incidence of AAA sac regression increased over time in the statin group, and no statistical difference was seen between the two groups at 2 years (no-statin group, 66.7%; statin group, 57.8%; P = .350). The difference between the changes in maximum AAA diameter was significant between groups at 1 year (no-statin group vs statin group, -4.9 mm ± 5.9; P = .041), but the difference did not reach statistical significance at 2 years (no-statin group, -10.0 mm ± 10.1; statin group, -8.0 mm ± 9.6; P = .306). Statin therapy was not associated with AAA sac regression on univariate (odds ratio [OR], 0.685; 95% confidence interval [CI], 0.310-1.516; P = .351) and multivariate analyses (OR, 0.617; 95% CI, 0.215-1.772; P = .369). CONCLUSIONS: Statin therapy had no effect on AAA sac regression at 2 years. There is insufficient evidence to recommend statin therapy for AAA sac regression.

The Influence of Statin Therapy on Restenosis in Patients Who Underwent Nitinol Stent Implantation for de Novo Femoropopliteal Artery Disease: Two-Year Follow-up at a Single Center.

PURPOSE: To determine whether statin therapy is associated with reduced restenosis following nitinol stent implantation for de novo femoropopliteal artery disease. MATERIALS AND METHODS: A total of 135 limbs in 135 patients (mean age, 72 y) implanted with nitinol stents in femoropopliteal occlusions were analyzed (statin arm, n = 91; nonstatin arm, n = 44). The patients were treated with one type of nitinol stent. RESULTS: At baseline, lesions and procedural characteristics were comparable between groups, except that the statin group had more hypertension, coronary artery disease, and hyperlipidemia. There were significant differences in the incidence of binary restenosis between groups at 1 year (45.5% for nonstatin group vs 28.6% for statin group; P = .05) and 2 years (56.8% for nonstatin group vs 38.5% for statin group; P = .04). Primary patency rates at 1 year were 50.5% in the nonstatin group and 72.5% in the statin group (P = .01). Two-year target lesion revascularization rates were 54.5% in the nonstatin group and 35.2% in the statin group (P = .03). On univariate analysis, statin therapy was associated with decreased relative risk of binary restenosis at 1 year (odds ratio [OR], 0.480; 95% confidence interval [CI], 0.227-1.014; P = .050). On multivariate analysis, statin therapy did not significantly affect the odds of binary restenosis (OR, 0.415; 95% CI, 0.071-2.437; P = .330). CONCLUSIONS: The incidence of binary restenosis was significantly lower in the statin group than in the nonstatin group following nitinol stent implantation for de novo femoropopliteal artery disease.

Single-Center Experience Comparing the Application of Small-Caliber versus Large-Caliber Arterial Access Closure in a Consecutive Series of Patients.

PURPOSE: To compare the closure of ≤ 8-F versus 9-F to 12-F femoral access using the 8-F Angio-Seal VIP device (St. Jude Medical, Inc, St. Paul, Minnesota). MATERIALS AND METHODS: In this investigator-initiated, retrospective analysis, a consecutive series of 137 patients (n = 92 male patients [67.2%]; overall mean age, 71.0 y ± 9.8) was evaluated. Common femoral artery access was performed in all patients, and either unfractionated heparin or bivalirudin was used for anticoagulation. Access site complications were defined as follows: type 0, no bleeding; type 1, no actionable bleeding; type 2, actionable bleeding. RESULTS: The 8-F Angio-Seal VIP device was used for closure of ≤ 8-F femoral access in 76 patients (55.5%) and for 9-F to 12-F femoral access in 61 patients (44.5%). Access site complications were observed after 8-F Angio-Seal deployment in 11 patients (8.0%) (≤ 8 F, n = 5 [6.6%]; 9-12 F, n = 6 [9.8%]; P = .54). Comparing ≤ 8-F with 9-F to 12-F femoral access, type 1 complications were observed in 3 and 6 patients (P = .19) and type 2 complications were observed in 2 and 0 patients (P = .50), respectively. All type 1 complications were managed by applying external compression. Type 2 complications (n = 2 pseudoaneurysms) were treated with thrombin injection in 1 patient and secondary percutaneous intervention in 1 patient. CONCLUSIONS: Use of the 8-F Angio-Seal for the closure of > 8-F femoral access is safe and effective. Complication rates when using the 8-F Angio-Seal for closure of ≤ 8-F and 9-F to 12-F femoral access are comparable.

Reliability and accuracy of simple visual estimation in assessment of peripheral arterial stenosis.

PURPOSE: To evaluate reliability, accuracy, and agreement of simple visual estimation (SVE) in determining the degree of peripheral arterial stenosis compared with calibrated measurements. MATERIALS AND METHODS: In 2 sessions, 23 interventionists with a wide range of experience and subspecialty training reviewed 42 angiographic images of lower extremity and carotid arteries (21 iliofemoral arteries and 21 carotid arteries). An independent physician measured all lesions using manual calipers. Intrarater and interrater reliability were assessed by intraclass correlation. A ± 5% error was considered the threshold for accuracy, and weighted κ statistics were computed to assess agreement with respect to the degree of stenosis (< 50%, nonsignificant; 50%-80%, significant; > 80%, severe). RESULTS: Intrarater reliability of SVE was 0.99, and interrater reliability was 0.83. Accuracy varied from 52.8% for images of severe stenosis to 26.5% and 18.1% for significant and nonsignificant stenosis, respectively (P < .001). Agreement between SVE and caliper with regard to degree of stenosis was good (weighted κ 0.56) overall with correct classification ranging from 92.6% for severe stenosis to 53.4% and 68.2% for significant and nonsignificant stenosis, respectively (P < .001). Misclassification of nonsignificant and significant stenosis was more frequent for carotid arteries than for lower extremities. CONCLUSIONS: Despite high reliability, SVE of peripheral arterial stenosis has limited accuracy in determining the exact degree of stenosis. Although severe stenosis is readily identified by SVE, arterial stenosis of < 80% is frequently overestimated, especially for carotid arteries, and should be confirmed by caliper assessment.

Lightweight bilayer barium sulfate-bismuth oxide composite thyroid collars for superior radiation protection in fluoroscopy-guided interventions: a prospective randomized controlled trial.

PURPOSE: To test whether newer bilayer barium sulfate-bismuth oxide composite (XPF) thyroid collars (TCs) provide superior radiation protection and comfort during fluoroscopy-guided interventions compared with standard 0.5-mm lead-equivalent TCs. MATERIALS AND METHODS: Institutional review board approval and written informed consent were obtained for this HIPAA-compliant study, and 144 fluoroscopy-guided vascular interventions were included at one center between October 2011 and July 2012, with up to two operators randomly assigned to wear XPF (n = 135) or standard 0.5-mm lead-equivalent (n = 121) TCs. Radiation doses were measured by using dosimeters placed outside and underneath the TCs. Wearing comfort was assessed at the end of each procedure on a visual analog scale (0-100, with 100 indicating optimal comfort). Adjusted differences in comfort and radiation dose reductions were calculated by using a mixed logistic regression model and the common method of inverse variance weighting, respectively. RESULTS: Patient (height, weight, and body mass index) and procedure (type and duration of intervention, operator, fluoroscopy time, dose-area product, and air kerma) data did not differ between the XPF and standard groups. Comfort was assessed in all 256 measurements. On average, the XPF TCs were 47.6% lighter than the standard TCs (mean weight ± standard deviation, 133 g ± 14 vs 254 g ± 44; P < .001) and had a significantly higher likelihood of a high level of comfort (visual analog scale >90; odds ratio, 7.6; 95% confidence interval: 3.0, 19.2; P < .001). Radiation dose reduction provided by the TCs was analyzed in 117 data sets (60 in the XPF group, 57 in the standard group). The mean radiation dose reductions (ie, radiation protection) provided by XPF and standard TCs were 90.7% and 72.4%, with an adjusted mean difference of 17.9% (95% confidence interval: 7.7%, 28.1%; P < .001) favoring XPF. CONCLUSION: XPF TCs are a lightweight alternative to standard 0.5-mm lead-equivalent TCs and provide superior radiation protection during fluoroscopy-guided interventions.

A cross-sectional study of outcomes for patients undergoing mechanical thrombectomy for pulmonary embolism during 2018-2022: Insights from the PINC AI Healthcare Database.

Background and Aims: Mechanical thrombectomy (MT) treatments for pulmonary embolism (PE) have yet to be compared directly. We aimed to determine if patient outcomes varied following treatment of PE with different MT devices. Methods: All PE encounters with an index treatment of MT between January 2018 and March 2022 were analyzed for in-hospital mortality, discharge to home, and 30-day readmission outcomes in the PINC AI™ Healthcare Database. MT devices used in each encounter were extracted from hospital charge description free-text fields using keyword text and fuzzy matching. Unadjusted and adjusted logistic regression was used to model outcomes by device. Results: A total of 5893 encounters were identified using MT as the sole index PE treatment and 1812 using MT with another treatment. Of these, 41% had insufficient information to identify the devices used (unspecified MT), 33% used the FlowTriever System (large-bore volume-controlled aspiration MT), 23% the Indigo System (continuous aspiration MT), and 3% some other MT. Large-bore volume-controlled aspiration MT was used with other treatments 13% of the time compared with 23% and 39% for unspecified MT and continuous aspiration MT, respectively. Adjusted logistic regression modeling revealed the odds of in-hospital mortality were significantly higher for patients treated with unspecified MT ([OR] = 1.42, 95% confidence interval [CI]: [1.10-1.83], p = 0.008) or continuous aspiration MT (OR = 1.63, 95% CI: [1.21-2.19], p = 0.001) compared with large-bore volume-controlled aspiration MT. Discharge to home was significantly lower in these same groups (OR = 0.84, 95% CI: [0.73-0.96], p = 0.01, and OR = 0.63, 95% CI: [0.53-0.74], p < 0.001, respectively), but readmission risks at 30 days were comparable (OR = 1.08, 95% CI: [0.84-1.38], p = 0.56, and OR = 1.20, 95% CI: [0.89-1.62], p = 0.24, respectively). Conclusion: PE outcomes and treatment patterns differ significantly based on the type of MT utilized. Clinical studies directly comparing MT treatments are needed to further understand optimal treatment of PE.